Clinical Trials List
Protocol NumberD9750C00001
NCT Number(ClinicalTrials.gov Identfier)NCT06005493
Active
2023-06-01 - 2026-12-31
Phase I
Recruiting3
ICD-10C16.0
Malignant neoplasm of cardia
ICD-10C7A.092
Malignant carcinoid tumor of the stomach
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9151.0
Malignant neoplasm of cardia of stomach
A Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5863, a T Cell-engaging Bispecific Antibody That Targets Claudin 18.2 (CLDN18.2) and CD3 in Adult Participants With Advanced or Metastatic Solid Tumors
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Tsai-Sheng Yang 無
- Ming-Mo Hou 無
- Wen-Chi Chou 無
- 黃文冠 無
- Wen-Chi Shen 無
- Po-Jung Su 無
- Hung-Chih Hsu 無
- Kuo-Chin Kao 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jeng-Shiun Du 無
- Wang Yao-Kuang 無
- 高育青 無
- Li-Tzong Chen 無
- Tsung-Jang Yeh 無
- Hui-Ching Wang 無
- 蘇勇曄 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Gastric Cancer 、Gastro-esophageal Junction Cancer 、Pancreatic Ductal Adenocarcinoma、 Esophageal Adenocarcinoma
Objectives
This is a first-in-human (FTIH) trial, primarily designed to treat advanced or metastatic solid tumors (including gastric cancer, gastroesophageal junction cancer, esophageal adenocarcinoma, and pancreatic duct cancer) for which standard care is inadequate or unavailable. adenocarcinoma) subjects to evaluate the safety, tolerability and preliminary efficacy of escalating doses of AZD5863. This trial will also characterize the pharmacokinetics (PK) and immunogenicity of AZD5863 and explore potential biological activities by evaluating pharmacodynamics and exploratory biomarkers, as well as anti-tumor activity.
Test Drug
AZD5863
Active Ingredient
AZD5863
Dosage Form
lyophilized drug product
Dosage
10 mg/vial
Endpoints
dose escalation
(1) To study the safety and tolerability of AZD5863 monotherapy or in combination, describe DLTs, and confirm MTD and/or RP2D in subjects with advanced or metastatic solid tumors harboring CLDN18.2 manifestations
dose expansion
(1) To study the safety and tolerability of AZD5863 monotherapy or in combination in subjects with advanced or metastatic solid tumors harboring CLDN18.2 manifestations
(2) To evaluate the preliminary anti-tumor activity of AZD5863 monotherapy or combination therapy in subjects with advanced or metastatic solid tumors harboring CLDN18.2 manifestations
(1) To study the safety and tolerability of AZD5863 monotherapy or in combination, describe DLTs, and confirm MTD and/or RP2D in subjects with advanced or metastatic solid tumors harboring CLDN18.2 manifestations
dose expansion
(1) To study the safety and tolerability of AZD5863 monotherapy or in combination in subjects with advanced or metastatic solid tumors harboring CLDN18.2 manifestations
(2) To evaluate the preliminary anti-tumor activity of AZD5863 monotherapy or combination therapy in subjects with advanced or metastatic solid tumors harboring CLDN18.2 manifestations
Inclution Criteria
Key Inclusion Criteria:
Age ≥ 18 at the time of signing the informed consent
Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
Predicted life expectancy of ≥ 12 weeks
Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
Must have received at least one prior line of systemic therapy in the advanced/metastatic setting
Age ≥ 18 at the time of signing the informed consent
Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
Predicted life expectancy of ≥ 12 weeks
Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
Must have received at least one prior line of systemic therapy in the advanced/metastatic setting
Exclusion Criteria
Key Exclusion Criteria:
Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy
Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
Cardiac conditions as defined by the protocol
History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
Participant requires chronic immunosuppressive therapy
Participants on anticoagulation therapy
Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy
Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
Cardiac conditions as defined by the protocol
History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
Participant requires chronic immunosuppressive therapy
Participants on anticoagulation therapy
The Estimated Number of Participants
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Taiwan
25 participants
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Global
480 participants
